mdi Europa has set up a checklist that is based on a formal template issued by the German competent authority. The template is used when reviewing the Technical Documentation, more… Read More
Tag: Templates
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices… Read More